PMA supplement
P150040 S003: VisuMax Femtosecond Laser
FDA PMA supplement · Panel Track · Carl Zeiss Meditec, Inc.
Key facts
| Original PMA | P150040 |
|---|---|
| Supplement number | S003 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | VisuMax Femtosecond Laser |
| Generic name | Femtosecond laser system for refractive correction |
| Applicant | Carl Zeiss Meditec, Inc. |
| Product code | OTL |
| Received date | Mar 23, 2018 |
| Decision date | Oct 4, 2018 |
| Docket number | 18M-3842 |
| Notice date | Oct 25, 2018 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: